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Completed

NCT Number: NCT05217017

French Version of Fear-Avoidance Component Scale (FACS-FR)

Chronic musculoskeletal disorders are global burden for economy. Fear-avoidance (FA) seems be a predictor for the transition from subacute to chronic pain. One of the most famous scales to access FA is the Tampa scale of kinesiophobia, but several responders think some items are not clear, too narrow or too general. A new scale, the Fear-Avoidance Components Scale (FACS) was developed by Neblett et al. in 2015 to assess FA. It is a comprehensive set of concepts that more effectively addresses all the essential issues of the FA concept than the current scales. The new scale comprehensively assesses all cognitive, emotional, and behavioral components related to the updated FA model by combining items from well-known scales in the context of the FA model with items on perceived injury-related victimization and blame. A French version of the FACS is currently lacking. The aim of this study is to provide a translation and validation of a French version of FACS in patients with musculoskeletal disorders.

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Key information

Conditions

Kinesiophobia Anxiety Disorders Chronic Pain Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Phobic Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche du CHUS (CRCHUS)

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

The process is done in two steps to allow the achievement of our two study objectives (translation and validation), with two different cohorts of patients.

First, for the French translation of the FACS, a pre-test with a first cohort of 30 patients will be performed. These patients will have to fill in the French version of the paper questionnaire and answer a second one on their interpretation and understanding of the questions. Each question will be evaluated by the patient. A report will be made with the patients' answers to the questionnaire and reported to the translation committee, then modifications will be made to the translation if necessary. If changes are made, a second pre-test will be done until no changes are needed.

In a second phase, once the French version is finalized, the second cohort of 50 patients will follow the patient schedule presented in Table I. In more detail, at the initial consultation, the diagnosis of chronic pain should be made by the center's orthopedist. At the same time, the orthopedist, resident, or research assistant will validate, through free and informed consent, whether or not the patient agrees to participate in the study, i.e., T0. At this T0, the patient will have to fill out the four questionnaires, which are FACS, Tampa scale for kinesiophobia French Canadian version (EKT-CF), Pain catastrophizing scale French Canadian version (PCS-CF) and Hospital anxiety and depression scale French version (HADS). The questionnaires will be completed in paper form.

At T1, i.e. seven days later, the patient will have to take the FACS French version again on the REDcap platform. This time frame is short enough to allow for a similar or even identical state of function as at T0 for the assessment of test-retest reliability. Patients with a significant change in status will be excluded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years old
  • Current chronic pain complaint is not surgically treated (at least 6 weeks of pain)
  • Not being currently treated by a physiotherapist for pain complaint
  • French language is mother tongue

Exclusion criteria

  • Pain from a non-musculoskeletal origin (e.g., tumour)
  • Neurological disease
  • Impaired cognition

Treatment and study plan

FACS

Diagnostic Test

Diagnostic Test: Assessment of disability and behavior (by questionnaires)

Primary outcomes

  1. FACS

    Time frame: day 0

    The fear-avoidance component scale evaluating fear-avoidance (for all participants) 20 items range from 0-100

  2. FACS

    Time frame: day 7

    The fear-avoidance component scale evaluating fear-avoidance (for all participants) 20 items range from 0-100

  3. TSK

    Time frame: day 0

    Questionnaire evaluating kinesiophobia (for all participants) 17 items total score from 17-68

  4. PCS

    Time frame: day 0

    Pain catastrophizing scale (for all participants) 13 items total score from 0-52

  5. HADS

    Time frame: day 0

    Hospital anxiety and depression scale is a questionnaire evaluating anxiety and depression (for all participants) 2 subscales: anxiety (7 items) and depression (7 items) Total score 0-21 per subscale

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

Psychometric Validation of the French Version of the Fear Avoidance Component Scale (FACS)

Acronym: FACS-Fr

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2022
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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